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BioSpace BioPharm Exec
Wednesday, August 31, 2011
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The Price of Confusion

It's been a confusing summer. Standard & Poor's now believes U.S. Treasury Bills are riskier than French government debt. British youth violently rioted and looted for days over nothing in particular. The markets have gone through wild gyrations as bulls and bears try to make each other blink. East Coast residents recently even felt the ground lurch under their feet.

The biotech industry has had its own little slice of confusion, too. This should be a great time for the industry. We've seen a rising number of approvals--the most in 20 years--for novel, life-saving products. These are the kinds of drugs that should find demand even if the economy is poised on the brink of a new recession. Yet analysts and investors suddenly find themselves deeply uncertain over what kinds of revenues these new products can fetch. More...

More By Karl Thiel

It's fascinating to watch the progress of Biogen Idec's daclizumab. Originally marketed to prevent transplant rejection, daclizumab (sold as Zenepax by Protein Design Labs, the predecessor to PDL Biopharma) saw slowing sales and was eventually withdrawn from the market. But Biogen acquired multiple sclerosis rights for the drug in 2006.

Researchers originally thought the drug, by blocking the activity of interleukin-2, would disrupt with the growth of T-lymphocytes, which in turn were thought to be responsible for demyelination. But it turns out daclizumab doesn't suppress T-cells, and actually increases the activity of natural killer cells--specifically CD56bright NK cells. But instead of these cells running out of control and damaging myelin, as it seemed reasonable to fear, they instead appear to regulate autoimmune response. The bonus is that the drug doesn't lower general immune response, meaning the drug may be less likely to be associated with opportunistic infection. -KT

Gilead Sciences, Inc. (GILD)'s Quad JOV Drug Shows Positive Results in Phase III Trial
More...

Biogen Idec, Inc. (Massachusetts) (BIIB) and Abbott Laboratories (ABT) Report Top-Line Positive Results for Daclizumab HYP Trial in RRMS
More...

Amgen (AMGN), Cytokinetics, Inc. (CYTK) Heart Failure Class Shows Promise in Phase II
More...

Endo Pharmaceuticals (ENDP) Terminates Pain Program After Failed Trial; Ends Pact With Grunenthal GmbH
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Topline Results for GlaxoSmithKline (GSK)'s Second Phase III Parkinson's Drug Study
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More Bench To Clinic News
Forest Labs and its embattled CEO Howard Solomon have had a good month. The Office of the Inspector General dropped its effort to bar Solomon from having any dealings with government healthcare programs--an effort to oust him after the company paid civil and criminal penalties for offering kickbacks to doctors who prescribed their drugs. HHS went from initially considering barring eight Forest execs--which would have effectively turned over the whole management of the company--to focusing on Solomon alone, to closing the case without further action. What that signals about the government's willingness to bar future violators is unclear, but the government continues to take a tougher stance.

Subsequent to that victory--and no doubt helped by the government's decision to back down--Forest won its proxy fight with activist investor Carl Icahn, getting their entire slate of 10 directors nominees elected "by a significant margin."
-KT

Forest Laboratories, Inc. (FRX) Defeats Icahn in Proxy Fight
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Government Drops Push to Ban Forest Laboratories, Inc. (FRX) CEO Solomon
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Roche (RHHBY) to Invest $200 Million for New Research Center, Creating 200 Jobs
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Pfizer Inc. (PFE) Cuts Reps Before Lipitor Patent Expires
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Dendreon Corporation (DNDN) Plunges on Slow Sales, Plans "Across the Board" Layoffs
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More Career Track News
Rumors abound. Will PPD be taken private? Will GlaxoSmithKline buy Human Genome Sciences? And then there are the deals some folks would rather not see--like the combination of Allos Therapeutics and AMAG Pharmaceuticals, two companies that have had very disappointing product launches (sort of a theme for this month). MSMB Capital Management would like to instead buy AMAG, prevent the merger, and fire the management. Finally, Qiagen and Pfizer continue to trend of linking new therapies to companion diagnostic--in this case, for non-small cell lung cancer.
-KT

Carlyle Group in Talks to Buy PPD, Inc. (PPDI) for as Much as $4.3 Billion
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AMAG Pharmaceuticals, Inc. (AMAG) Investor MSMB Makes $378 Million Takeover Bid for Firm to Stop Merger With Allos Therapeutics, Inc. (ALTH)
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4-Antibody AG Forms Collaboration with Human Genome Sciences, Inc. (HGSI)
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QIAGEN N.V. (QGEN) and Pfizer Inc. (PFE) Partner to Develop Companion Diagnostic for Novel Compound in Global Clinical Trials for Lung Cancer
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Novartis Corporation (NVS) Takes Option on TRANSGENE (TRGNY) Cancer Vaccine; Transgene Gets $10 Million, Milestones Could Reach $950 Million
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More Golden Handshakes News

Top Jobs
• BioChina (Hangzhou, China)

PTM BioLab (Hangzhou) Co. Ltd.
Vice President
Major Responsibilities: Responsible for execution leadership input in the overall direction of the company; Build and lead a team to optimize resources and organizational performance; Responsible for the international marketing development in the community etc.

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CMC Biologics
Business Development Vice President
Primary responsible for either West Coast or East Coast sales, focusing on the growth of CMC Biologics by identifying, evaluating, recommending and negotiation value-added development and manufacturing contracts. The successful candidate will serve as a key member of the U.S. Business Development Team.

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MedImmune, LLC
Vice President, Clinical / R&D Quality
Leads and directs the strategic direction of the Clinical/R & D Quality Operations organization and is accountable and responsible for the design, development, execution and administration of a GxP Quality System meeting all MedImmune and regulatory agency Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Pilot Plant Good Manufacturing Practices (GMP) compliance requirements.

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Versartis, Inc.
Senior Director, Program Management
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Biotech Beach Career Fair Biotech Beach Career Fair
San Diego Marriott La Jolla, Thursday, September 22, 2011, 1pm to 6pm . Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Southern California region.
BioMidwest Career Fair BioMidwest Career Fair
Chicago Marriott Oak Brook, Tuesday, October 4, 2011, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Midwest region.
Enobia raised a heady $40 million round of financing, its fifth, not just from VC firms but from an undisclosed group of pharmaceutical companies. That's certainly where Enobia's management will be looking first when it partners its lead compound, an enzyme replacement therapy for hypophosphatasia, a rare metabolic bone disease. And VIVUS is filling out its coffers as it continues to pursue development of Qnexa for obesity, diabetes, and sleep apnea, as well as its erectile dysfunction product.
-KT

VIVUS, Inc. (VVUS) Adds $45.8 Million
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KalVista Pharmaceuticals Launched With $13 Million Series A Funding to Develop Eye Drugs
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Asymchem Laboratories, Inc. Announces $39 Million in VC Funds
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Yaupon Therapeutics Inc. Secures $14.4 Million in Series D Financing
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Enobia Pharma Raises US $40 Million
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More Money Talk News

It's been an odd month of the legal front. Pfizer has "voluntarily" given information to the Department of Justice and the SEC about potential overseas bribes. The DOJ has warned drug companies that it is getting more serious about criminal prosecutions over bribes, and Pfizer apparently took them seriously. Many companies (not just in the pharma industry, mind you) pay fines to government watchdogs without admitting wrongdoing and seemingly without making serious subsequent changes in behavior. Is the risk-benefit math changing?

Then there's the lawyer for Baxter, caught on tape as he offered to pay off an opposing expert in a pending lawsuit "if he would leave the country on a key court date to undermine the case," as Businessweek describes it. Check out the juicy details on the tape, and you'll not be surprised why Baxter was quick to sever all ties with the lawyer.
-KT
Baxter International, Inc. (BAX) Lawyer Taped Trying to Foil Lawsuit
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Amarin Corporation PLC (AMRN) Gets Final Rejection on Key Drug Patent
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Pfizer Inc. (PFE) Confesses About "Potential" Overseas Bribes
More...

Pfizer Inc. (PFE) Wins Viagra Patent Battle Against Teva Pharmaceutical Industries Limited (TEVA)
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Feds Probe Marketing of 3 Merck & Co., Inc. (MRK) Drugs
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More Legal Briefs News
It's not uncommon for biotechs that have won their way to FDA approval see their stock decline in the wake of the good news. But for Seattle Genetics, the decline has been much faster and harder than usual. That's because investors see the drug--which could run over $100,000 for a typical course of treatment--as a potential echo of Dendreon's Provenge debacle. Zelboraf is the other high-profile approval this month. If the original innovator, Plexxikon, hadn't been snatched up by Daiichi, we'd get a very interesting look at how that stock is trading right now.
-KT
FDA Approves Seattle Genetics, Inc. (SGEN) Cancer Drug Adcetris to Treat Two Types of Lymphoma
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FDA Approves Roche (RHHBY)'s Skin Cancer Drug Zelboraf
More...

Regeneron Pharmaceuticals, Inc. (REGN) Falls on FDA Delay of Eye Drug
More...

FDA Approves Gilead Sciences, Inc. (GILD)'s Once-Daily HIV Treatment Complera
More...

Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA
More...


More Rockville Files News

Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at Karl.thiel@biospace.com.

BioSpace, Inc.
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BioSpace, Inc.
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San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217



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